BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 1821464 · Received August 25, 2010

    Report

    Report Number
    1721279-2010-00052
    Event Type
    Death
    Date Received
    August 25, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD-REMOVAL PROCEDURE CONDUCTED IN THE CARDIAC CATHETER LAB. THE PT HAD A TOTAL OF 3 LEADS (CS, RV AND LV) WITH AN UNK IMPLANTATION DATE. PT HAD A HISTORY OF CHRONIC POCKET INFECTIONS, THIS BEING HIS 2ND INFECTION/PROCEDURE IN UNDER 6MTHS. THE MD PREPPED THE CS LEAD WITH THE LLD-EZ, LASED AND SUCCESSFULLY REMOVED THE LEAD WITH A 12F SLS. THE SECOND LEAD (ATRIAL) WAS ALSO PREPPED WITH THE LLD-EZ, LASED AND SUCCESSFULLY REMOVED WITH A 14F SLS AND A 14F VISISHEATH. THE LAST LEAD TO BE REMOVED (LV) WAS PARTICULARLY DIFFICULT TO REMOVE. PREPPED WITH THE LLD-EZ AND BEGAN LASING WITH THE 16F SLS AND A 16F VISISHEATH, THE MD WAS ABLE TO LASE PAST THE SVC (BETWEEN THE 1ST AND 2ND COIL) WITH SUCCESS. HOWEVER, HE WAS UNABLE TO PROGRESS FURTHER DUE TO THE PT'S VITAL SIGNS DECLINE. A CODE WAS CALLED, CPR WAS INITIATED, AND THE ANESTHESIOLOGIST WAS CALLED IN AND QUICKLY ESTABLISHED AN AIRWAY. THIS PT HAD A DNR ON FILE; THE FAMILY WAS NOTIFIED OF THE RECOVERY EFFORTS AND INSTRUCTED THE PHYSICIAN TO STOP CPR. NO SPNC DEVICES WERE RETURNED FOR ANALYSIS. AN INTERNAL LHR REVIEW ON THE LAST 3 LOTS DELIVERED PRIOR TO THE CASE (LOT#S C10B10C, C09L19M, C09K21E) FOUND NO NONCONFORMANCES OR DEVICE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 16F SLS MFA SPECTRANETICS CORP. 500-013 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death CVX-300 EXCIMER LASER (SERIAL# (B)(4))| LLD-EZ (518-062/UNK SERIAL #)| 16F VISISHEATH (501-116/UNK SERIAL #)